Paralegal, Regulatory

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. 

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. 

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission. 

The regulatory legal team is a dynamic, collaborative and growing team within the legal department.  We work across all businesses and functions globally; partnering with key stakeholders in the business, regulatory, quality, medical, R&D, finance and other key teams to advise on numerous complex and often novel regulatory issues.  

The team regularly partners with our legal colleagues on the commercial and functional legal side, as well as our Ethics & Compliance colleagues, to identify issues and work towards solutions that both protect and move the organization forward.  

Members of this team have the opportunity to help develop and drive new initiatives, processes, and engagement with stakeholder to reshape how we advise and help to solve regulatory issues across the organization.      

Qualifications:

• General understanding of legal environment and resources.
• Knowledge and familiarity with pharmaceutical or medical device regulatory issues or laws is highly desirable. 
• Experience in gathering and compiling data for reporting to various government agencies. 
• Experience in assisting lawyers in developing and managing policies and trainings to educate the business and function on key legal issues.
• Experience in researching laws, gathering data, and preparing documents to assist the lawyers. 
• Ability to prioritize workload and meet deadlines in a busy environment with competing priorities.
• Attention to detail.
• Ability to work independently on repetitive tasks.
• Well-developed communication skills, both written and verbal, strong organizational skills, and good research and analytical skills.
• Advanced skills needed are with MS Office 365.

Essential Duties and Responsibilities:

• Support attorneys in various aspects of regulatory legal work.
• Develop a knowledge of relevant laws, regulations, rules, and procedures and conduct legal research from time to time.
• Apply substantial analytical skills regarding various rules and regulatory requirements to ensure that regulatory filings and reports are properly managed and administered.
• Prepare and review forms, reports, and applications in accordance with federal and state regulations and requirements under the supervision of the assigned attorney.
• Generate monthly status reports of outstanding issues and requests.
• Organize and maintain files, regulatory submissions, attorney notebooks and other materials.
• Support records management.
• Act as liaison for the regulatory law group with other members of business units/functions, law department and external parties.
• Support the legal team in the development of discrete legal strategies for business units/functions.
• Leverage existing technology systems and provide reports.

Education and Experience:

• Bachelor's Degree, and paralegal certification or specialty paralegal courses
• At least 5 years of paralegal experience, law firm and/or corporate

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Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                               
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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Qualifications: